Merck & Co (NYSE:MRK)

Merck & Co has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to their investigational drug, sacituzumab tirumotecan (sac-TMT). This designation is for the treatment of certain patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that exhibits epidermal growth factor receptor (EGFR) mutations, who have undergone previous treatment.

The pharmaceutical giant is currently accelerating the global clinical development program for sac-TMT, which is being evaluated both as a standalone treatment and in combination with KEYTRUDA, Merck's anti-PD-1 therapy. This development includes 10 ongoing Phase 3 studies targeting various solid tumors.

Sac-TMT has also marked a significant milestone internationally, having received its first marketing authorization in China. The National Medical Products Administration (NMPA) of China approved the drug for use in certain adults with unresectable locally advanced or metastatic triple-negative breast cancer who have already received at least two prior systemic therapies.

Kelun-Biotech, a biopharmaceutical company, retains the rights to develop, manufacture, and commercialize sac-TMT within the Greater China region. This recent FDA designation is expected to expedite the development and review of sac-TMT in the United States, given its potential to offer substantial improvement over existing therapies for serious or life-threatening diseases.

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